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Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cefaly® Abortive Program device
Sponsored by
Cefaly Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age from 18 to 65 years on the day of signing the informed consent form
  • ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine
  • Migraine onset before the age of 50 years
  • Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening
  • Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent
  • Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events (AE) collecting form)

Exclusion Criteria:

  • Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches
  • Patient has more than 15 headache days per month
  • Patient having received supraorbital nerve blocks in the prior 4 months
  • Patient having received Botox treatment in the prior 4 months
  • Modification of a migraine prophylaxis treatment in the previous 3 months
  • Diagnosis of other primary headache disorders, except rare (< 4) tension-type headaches per month
  • Diagnosis of secondary headache disorders included Medication Overuse Headache
  • Patients abusing opioids or user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
  • Implanted metallic or electronic device in the head
  • Cardiac pacemaker or implanted or wearable defibrillator
  • Patient having had a previous experience with the Cefaly® device
  • Migraine Aura without headache
  • Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening visit (Visit 1)
  • Patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site

Sites / Locations

  • Rochester Clinical Research, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack

Outcomes

Primary Outcome Measures

Pain Freedom (PF) at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.

Secondary Outcome Measures

Pain Relief (PR) at 2 Hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
Migraine-associated Symptoms Freedom at 2 Hours
The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.
Use of Rescue Medication Between 2 and 24 Hours
The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.
Sustained Pain Freedom at 24 Hours
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.

Full Information

First Posted
July 13, 2017
Last Updated
July 9, 2018
Sponsor
Cefaly Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03217968
Brief Title
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
Official Title
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device: Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cefaly Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack. This open clinical trial will study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to development of a sham-controlled trial.
Detailed Description
The main objective of this study is to have a pilot assessment of the efficacy of the Cefaly® Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. That is to say having pilot data to assess the efficacy of the Cefaly® Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
120 minutes of Cefaly® Abortive Program device stimulation as abortive treatment of an early stage migraine attack
Intervention Type
Device
Intervention Name(s)
Cefaly® Abortive Program device
Intervention Description
The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).
Primary Outcome Measure Information:
Title
Pain Freedom (PF) at 2 Hours
Description
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.
Time Frame
2 hours
Title
Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours
Description
The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Pain Relief (PR) at 2 Hours
Description
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.
Time Frame
2 hours
Title
Migraine-associated Symptoms Freedom at 2 Hours
Description
The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.
Time Frame
2 hours
Title
Use of Rescue Medication Between 2 and 24 Hours
Description
The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.
Time Frame
Between 2 and 24 hours
Title
Sustained Pain Freedom at 24 Hours
Description
The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 65 years on the day of signing the informed consent form ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in the International Classification of Headache Disorders (ICHD)-III beta (2013) section 1, migraine (8), with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine Migraine onset before the age of 50 years Having between 2 and 8 moderate or severe migraine attacks (Grade 2 or 3) per month in each of the two months prior to screening Patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent Patient is able to read and understand the written information (instruction sheet, paper diary and Adverse Events (AE) collecting form) Exclusion Criteria: Patient has difficulty distinguishing his/her migraine attacks from tension-type headaches Patient has more than 15 headache days per month Patient having received supraorbital nerve blocks in the prior 4 months Patient having received Botox treatment in the prior 4 months Modification of a migraine prophylaxis treatment in the previous 3 months Diagnosis of other primary headache disorders, except rare (< 4) tension-type headaches per month Diagnosis of secondary headache disorders included Medication Overuse Headache Patients abusing opioids or user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence Implanted metallic or electronic device in the head Cardiac pacemaker or implanted or wearable defibrillator Patient having had a previous experience with the Cefaly® device Migraine Aura without headache Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening visit (Visit 1) Patients not having the ability to use appropriately the device and/or to perform themselves or bear the first 20-minute stimulation session during the training session at the study site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph MANN, M.D.
Organizational Affiliation
Rochester Clinical Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Abortive Treatment of Migraine With the Cefaly® Abortive Program Device

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